Glossary:TAG-00246-Inv-hte

Glossary > Investigator responsibilities

Investigator responsibilities
Tag-ID	TAG-00246-Inv-hte
English	Investigator responsibility / Investigator obligations / Investigator duties
French	Responsabilité de l'investigateur / Obligations de l'investigateur / Tâches de l'investigateur
German	Verantwortung des Prüfers / Pflichten des Prüfers / Aufgaben des Prüfers

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001	HM	§ 40d	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002	HM	§ 40d	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003	HM	§ 40d	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001	MD	§ 62	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002	MD	§ 62	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003	MD	§ 62	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65	MD	§ 65	DE	DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution	HM	D Investigator/Institution	EN	GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1	MD	10.1	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi)	HM	§ 312.53 (c) (vi)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii)	HM	§ 312.53 (c) (vi) - (vii)	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.60-001	HM	§ 312.60	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.60-002	HM	§ 312.60	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.61	HM	§ 312.61	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.69	HM	§ 312.69	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart E	MD	Subpart E	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.100	MD	§ 812.100	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b)	MD	§ 812.110 (b)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c)	MD	§ 812.110 (c)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4)	MD	§ 812.43 (c) (4)	EN	USA 21 CFR Part 812 09-Apr-2025
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A.	G	III. A.	EN	USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.	G	IV.	EN	USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3	G	1.3	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3	HM	10.3	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation	HM	3.2 - Consultation	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1	HM	4.1	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15	HM	4.15	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3	HM	4.3	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard	HM	4.4 - immediate hazard	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6	HM	4.6	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator	HM	7.1 - Investigator	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995